Status:
TERMINATED
A Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope
Lead Sponsor:
Yale University
Conditions:
Digestive System Diseases
Eligibility:
All Genders
18+ years
Brief Summary
The goal of the project is to determine whether confocal endomicroscopy can be used to identify and discriminate among dysplastic, neoplastic, and nonneoplastic tissue, as compared with histologic spe...
Detailed Description
This study was amended from it's initial design to increase the number of patients to 200. The study was terminated in July 2016 after 106 patients were enrolled and had completed the study.
Eligibility Criteria
Inclusion
- Patients with long-standing reflux symptoms, undergoing surveillance for Barrett's esophagus, or scheduled for endoscopic therapy with esophageal dysplasia
- Patients undergoing ERCP for known or suspected biliary strictures.
Exclusion
- have a known allergy or have had a prior adverse reaction to fluorescent contrast agents or chromoendoscopy stains
- are younger than age 18 or who are mentally or legally incapacitated or unable to give informed consent
- are pregnant or breastfeeding
- patients with advanced esophageal cancer
- acute gastrointestinal bleeding
- coagulopathy
- impaired renal function
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01262937
Start Date
July 1 2009
End Date
July 1 2016
Last Update
February 26 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520